Additive manufacturing for customized implants

12.05.2025

Together with the Mass Personalization Center, Fraunhofer IPA has developed a guideline for the safe use of additive manufacturing for patient-specific implants. The aim is to enable medical technology companies to introduce this technology in a structured and cost-efficient manner.

Additive processes such as Laser Powder Bed Fusion (PBF-LB/M) offer great advantages in the manufacture of individual products, such as dental implants or prostheses. They enable the cost-effective production of complex geometries that are precisely tailored to the anatomy of individual patients.

The new guidelines address the challenges of risk management in particular. As the geometries and therefore also the material properties of individual products change, it is difficult to provide standardized proof of safety. The guide is based on the ISO 14971 standard and offers a practical framework for predicting process stability and minimizing risk.

For a detailed look at the guide and the innovative possibilities of additive manufacturing, it is worth taking a look at the Fraunhofer IPA website:
Better safe than sorry: Additively manufactured customized products in medical technology - Fraunhofer IPA